For many, a bad night’s sleep can be chalked up to a late night out, stress and such. However, multiple nights of restless sleep could mean something more. Insomnia is among the two most common sleep disorders in Australia, with the second being obstructive sleep apnea. About 60% of Aussies display symptoms of insomnia. With a major portion of the population facing challenges related to sleep, the importance of addressing sleep disorders becomes evident.

An ASX-listed company on the job is Avecho Biotechnology (ASX: AVE), a biotech company that develops and commercialises products using its proprietary Tocopheryl Phosphate Mixture (“TPM®”) drug delivery system (enabling greater solubility of injectable drugs than traditional methods). The Company has received Ethics Approval for its pivotal Phase 3 clinical trial testing its oral CBD TPM-enhanced soft-gel capsule for insomnia, following the submission of amendments to the study in December 2023. 

Avecho CEO, Dr Paul Gavin, said, “We are very pleased to complete one of the final steps in our Phase 3 trial program prior to commencement, with the formal approval of changes that will allow for a more efficient study. In addition to this, we’ve continued preparations with our team of clinical trial providers, finalised the key manufacturing elements, and we have had constructive dialogue with the TGA. We expect that all of this sets a strong foundation for what will be the largest and most robust Phase 3 CBD study in Australia thus far. We are now excited to start.” 

In CY23, Avecho saw a revenue decline of 58.1% to $473.5k against a loss of $3.4 million. The revenue decline was driven by reduced Vital ET® (a skincare ingredient), sales as well as increased investment in R&D. In the same period, it raised about $8 million to start these Phase 3 clinical trials.

Avecho’s Phase 3 study will test its oral CBD TPM-enhanced soft gel capsule produced by Procaps, an American manufacturing firm, for the treatment of insomnia. It is targeting enrolment of 519 patients across three treatment groups to compare nightly CBD doses of 75 and 150mg CBD with placebo over an eight-week dosing period. 

The approval encompasses measures aimed at streamlining and enhancing the efficiency of the trial. This involves reinforcing the planned study design, distinct from previous unsuccessful Phase 3 trials for CBD in treating insomnia in Australia. Moreover, it is working on effectively deploying funds obtained by the Company following its capital raise in 2023.

Five sites will be used for the study, located in Melbourne, Sydney, Central Coast, Brisbane, and Perth. These additions expand the trial’s reach and potential participant pool.

Besides the soft gel capsules, the Company expanded its cannabinoid portfolio last year. It wrapped up the development of its first-generation TPM gummies containing cannabinoids. With the inclusion of edibles, Avecho’s current cannabinoid portfolio now contains four different dosage forms with increased absorption – oral oils, oral soft-gel capsules, oral edibles and topical gels. 

Avecho’s Phase 3 study is taking place at a pivotal moment, considering Australia’s regulatory environment that allows OTC registration of pharmaceutical CBD products. This presents a notable commercial opportunity, as OTC products can be accessible directly to consumers without prescriptions. 

With insomnia being a widespread problem and existing treatments posing various limitations, Avecho’s market entry has the potential fulfil a substantial unmet medical need.